Z-1514-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2026
- Initiation Date
- January 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units (OUS only)
Product Description
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Reason for Recall
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
Code Information
Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;